Janni W, Bergauer F, Rjosk D, Lohscheidt K, Hagena F W
Frauenklinik, Klinikum Innenstadt, Ludwig-Maximilians-Universität, München.
Zentralbl Chir. 2001 Jan;126(1):32-8. doi: 10.1055/s-2001-11725.
In several studies, low-molecular-weight-heparins (LMWH) have been shown to be as effective in the prevention of deep vein thrombosis (DVT) as unfractionated heparin. However, different LMWHs vary significantly in their pharmacokinetic profile and bioavailability pattern. It remains unknown, whether these pharmacological differences result in a clinically divergent behavior.
Safety and antithrombotic efficacy of three LMWHs, certoparin (18 mg), dalteparin (30 mg) and enoxaparin (24 mg), were compared in a prospective, randomized controlled trial involving 188 patients undergoing knee or hip replacement or spinal surgery. Efficacy was assessed by changes in venous flow patterns between pre- and postoperative Doppler sonography. The clinical endpoint for the assessment of safety were intra- and postoperative bleeding, changes in activated partial thromboplastin time (APTT) and thrombin clotting time (TCT), local hematoma and local infections.
Two verified DVTs (1.1%) were observed in the study, leading to no statistical difference in the antithrombotic efficacy of the used LMWHs. In 21 patients (11.2%) local hematoma or local infections complicated the postoperative course. Of these 21 patients, 13 belonged to the certoparin group, compared to 4 patients each in the other groups (p < 0.01). An allergic reaction occurred in only one case treated with dalteparin. No differences between the groups were observed in terms of intra- and postoperative bleeding, APTT, TCT and blood count.
The results of this study suggest, that all three LMWHs are equally efficacious in the prophylaxis of DVT in high risk patients after orthopedic surgery. Larger randomized controlled trials are necessary to confirm this conclusion and to evaluate the clinical relevance of the observed differences in postoperative complications.
在多项研究中，低分子量肝素（LMWH）已被证明在预防深静脉血栓形成（DVT）方面与普通肝素同样有效。然而，不同的低分子量肝素在药代动力学特征和生物利用度模式上存在显著差异。这些药理学差异是否会导致临床上的不同表现仍不清楚。
在一项前瞻性、随机对照试验中，比较了三种低分子量肝素，即克赛（18毫克）、达肝素（30毫克）和依诺肝素（24毫克）的安全性和抗血栓疗效，该试验涉及188例接受膝关节或髋关节置换术或脊柱手术的患者。通过术前和术后多普勒超声检查静脉血流模式的变化来评估疗效。评估安全性的临床终点是术中和术后出血、活化部分凝血活酶时间（APTT）和凝血酶凝血时间（TCT）的变化、局部血肿和局部感染。
研究中观察到2例经证实的深静脉血栓形成（1.1%），所使用的低分子量肝素的抗血栓疗效无统计学差异。21例患者（11.2%）术后出现局部血肿或局部感染。在这21例患者中，13例属于克赛组，其他组各有4例（p<0.01）。仅1例接受达肝素治疗的患者发生过敏反应。各组在术中和术后出血、APTT、TCT和血细胞计数方面未观察到差异。
本研究结果表明，这三种低分子量肝素在预防骨科手术后高危患者深静脉血栓形成方面同样有效。需要进行更大规模的随机对照试验来证实这一结论，并评估观察到的术后并发症差异的临床相关性。
